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National MS Society and University of Iowa Launch $1 Million Clinical Trial to Test Dietary Approaches to Treating Fatigue in MS

August 24, 2016

Summary
  • The National MS Society has just committed over $1 million to support a clinical trial led by Dr. Terry Wahls to compare the ability of two popular diets to treat multiple sclerosis-related fatigue.
  • The award helps advance the Society’s Wellness research goals to help people know what they can do today to feel their best, and whether lifestyle interventions can impact the course of MS.
  • This financial commitment is the latest in the Society’s relentless research efforts to move us closer to a world free of MS, and part of a projected investment of $50 million in 2016 alone to support more than 380 new and ongoing studies around the world.
  • This trial is recruiting participants with relapsing-remitting MS who experience fatigue, and who live within a 500-mile radius of Iowa City, IA. See below for details about participating and Frequently Asked Questions about the study.
Details

The National MS Society has just committed over $1 million to support a clinical trial at the University of Iowa led by Terry Wahls, MD, to compare the ability of two popular diets to treat MS-related fatigue, a disabling symptom that can significantly interfere with a person’s ability to function at home and work. This financial commitment is the latest in the Society’s relentless research efforts to move us closer to a world free of MS, and part of a projected investment of $50 million in 2016 alone to support more than 380 new and ongoing studies around the world aimed at stopping the disease in its tracks, restoring function, and ultimately ending MS forever.
 
“The National MS Society is committed to identifying wellness solutions to help people live their best lives,” noted Bruce Bebo, PhD, the Society’s Executive Vice President, Research.  “We’re very pleased to support a rigorous clinical trial to test the ability of two popular MS dietary approaches to address the disabling symptom of fatigue,” he added. 

“Together with the National MS Society, and this grant, we will be able to take our long-standing work even further, examining how food and nutrients can impact the lives of people with multiple sclerosis,” said Dr. Wahls.
 
Background: Wellness – and the strategies needed to achieve it – is a high priority for people living with MS and for National MS Society programs and research.  Research studies in the area of dietary approaches have generally been of inadequate size and design to provide useful information about dietary strategies in MS.  This new trial takes a carefully designed approach to understanding the potential impact of diet on fatigue and possibly other symptoms commonly experienced by people living with MS.
 
Terry Wahls, MD, created the Wahls Protocol diet after being diagnosed with MS herself. She’s spent more than a decade studying the origins of certain foods and vitamins and their effects on the body. The Wahls Protocol follows a modified Paleolithic diet that doesn’t include grains, eggs, dairy products, legumes and nightshade vegetables, but places a heavy emphasis on vegetables, fruit, meat and fish.
 
Roy Swank, MD, PhD, began studying MS in 1948. He created the low saturated fat Swank Diet around 1950 after he observed a higher incidence of MS in geographic areas where people ate meat, milk, eggs and cheese – foods that are high in saturated fat – and a lower incidence in areas where people ate fish.  He spent more than 50 years recommending this diet to his patients and monitoring their health.
 
Both diets have been shown to have a positive impact on patients with MS.
 
The Study: Study investigators will be recruiting 100 people with relapsing-remitting MS who experience fatigue to enroll in the 36-week clinical trial. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow a low saturated fat diet (Swank diet) or a modified paleolithic diet (Wahls diet), for 24 weeks. Their health and activities will be extensively monitored during the study.
 
This study is currently recruiting participants. Participants must live within a 500-mile radius of Iowa City, IA. This includes the states of Iowa, Illinois, Indiana, Missouri and Wisconsin, and parts of Arkansas, Kansas, Kentucky, Michigan, Minnesota, Nebraska, North Dakota, Ohio, Oklahoma and Tennessee. Individuals interested in being considered for enrollment in this study may complete screening questionnaires and use code: JMJPYEJHP.  For questions, please email MSDietStudy@healthcare.uiowa.edu or call 319-384-5053.


Frequently Asked Questions: New Clinical Trial of Dietary Approaches to Treating MS Fatigue

Q. Why is the National MS Society investing research money in diet studies?
A. Wellness – and the strategies needed to achieve it – is a high priority for people living with MS and for National MS Society programs and research.  For the most part, research studies in the area of dietary approaches have generally been of inadequate size and design to provide useful information about dietary strategies in MS. This trial takes a carefully designed approach to understanding the potential impact of two widely used MS-related diets on fatigue and potentially other symptoms commonly experienced by people living with MS.

Q. Why is the Society giving money to Dr. Wahls, who is already profiting from the promotion of her diet?
A. First, when the Society makes a research grant, the funds associated with the grant go to the investigator’s institution – the University of Iowa  – and are administered by the university, not the investigator. Second, as with any clinical trial that the Society supports, the trial was carefully reviewed by independent scientific experts. They assessed the trial for both its scientific rigor, but also looked closely at the design to ensure there were no biases that might influence outcomes or interpretation of the results. Third, the funding agreement between the Society and the University of Iowa has strict provisions to ensure compliance with conflict of interest policies including disclosure of conflicts and issues surrounding monetary rewards or other tangible benefits derived from this research. For ongoing assurances, the Society is appointing a data and safety monitoring board to monitor safety of participants and to oversee implementation of the study to ensure it complies with best practices for scientific validity and objectivity, as well as adherence to the study protocol.  Lastly, the agreement with the University prohibits use of the Society’s name, logo or trademarks to promote any activity, product, or enterprise without the express written permission of the Society.

Q. What is this clinical trial testing?
A. This trial is comparing the ability of two different dietary approaches to reduce MS-related fatigue. Participants will be randomly assigned to follow a low saturated fat diet (Swank diet) or a modified paleolithic diet (Wahls diet), along with specific nutritional supplements, and will keep careful food diaries. Their health and activities, particularly physical activity level, will be extensively monitored before and during the study. The trial will last 36 weeks.
 
Q. What is the low saturated fat (Swank) diet?
A. The Swank diet, developed by the late Dr. Roy Swank, limits intake of saturated and unsaturated fats and oils, eliminates processed foods containing saturated fats, eliminates red meat for the first year, and includes eating fruits and vegetables, nonfat dairy products as well as whole grain cereals and pastas.
 
Q. What is the modified paleolithic (Wahls) diet?
A. The paleolithic diet involves eating natural foods while avoiding highly processed food, especially high carbohydrate foods that significantly raise blood sugar; and also emphasizes the intake of game (non-domesticated) meats and plant-based foods (fruits, roots, and nuts). The modified paleolithic (Wahls) diet also eliminates foods to which some individuals may be sensitive, including grains, dairy, legumes (including soy), eggs, and nightshades (tomatoes, potatoes, eggplant and peppers), but continues to stress a high intake of vegetables.
 
Q. How long will it take before the results of this trial are available?
A.  About four years. Clinical trials generally take many months to establish processes, convene a safety monitoring committee and to recruit all participants. Once it has begun, the actual study takes 36 weeks for each individual enrolled. The results can only be evaluated after all participants have completed all testing involved in the study, and then it usually takes months to evaluate the results, write a paper describing the results, and then getting it published in a peer-reviewed medical journal. Given this, it is likely that study results will be released in 2020.
 
Q. Besides fatigue, what other impacts are being tracked during the trial?
A. Participants will be monitored to track their physical activity, nutritional status, mobility, cognition and mood, and will also be monitored for potential side effects.
 
Q. Are there any potential side effects or risks associated with these diets?
A. Yes. Some restrictive diets may lead to vitamin or mineral deficiencies, which may impact overall health. The paleo diet can result in deficiencies in folic acid, thiamine and vitamin B6 (due to reduced intake of cereals), calcium and vitamin D (due to lack of dairy intake) and insufficient caloric intake without appropriate nutritional advice. Although no definite deficiencies would be expected to develop from the Swank diet, a recent study showed that people following this diet were consuming less than the recommended levels of vitamin A, C, E and folate. For these reasons, this clinical trial includes nutritional supplements for all participants and careful monitoring of potential side effects.
 
Q. How do I find out whether I am eligible to participate in this trial?
A. There are specific criteria established for determining who is eligible. People with relapsing-remitting MS who are experiencing fatigue and live within 500 miles of Iowa City will be considered for enrollment. Individuals who wish to be considered may complete a screening questionnaire at: https://redcap.icts.uiowa.edu/redcap/surveys/ and use code:  JMJPYEJHP.  For questions, please email MSDietStudy@healthcare.uiowa.edu or call 319-384-5053.
 
Q. Can a potential study participant be on an MS disease-modifying therapy?
A. Yes. Enrolled participants will be asked to continue their usual medications during the study, and also to maintain their usual physical activities and stress reduction regimens, unless their physician or physical therapist recommends changes.
 
Q. I have progressive MS.  Why isn’t the trial including people with progressive MS?
A. The decision to include only individuals with relapsing-remitting MS was made after careful consideration. One reason is that many studies have difficulty recruiting enough participants, and since there are more people who have relapsing-remitting MS than who have specific forms of progressive MS, the study is more likely to achieve its recruitment goals. Another reason is that including both relapsing-remitting and progressive participants would require recruitment of many more people,  since the analysis of the results would have to make provisions for examining possible differences in the response of relapsing versus progressive participants. This would raise the cost of the study beyond what is feasible.
 
Q. I have MS and I don’t live near Iowa. Is there any reason why I shouldn’t try one of these diets on my own?
A. Unless you have an allergy or medical condition that would prohibit any of the foods suggested for these diets, there’s no reason not to try one of these diets. However it is a good idea to check with your healthcare provider before undertaking any major change in your dietary habits. Also, be sure to get the full details about these diets and their recommended nutritional supplements so that you get the nutrition you need while you are trying one of these approaches.
 
Q. What diet is recommended for people with MS?
A.  Although there’s no proven “MS diet,” what and how you eat can make a difference in your energy level, bladder and bowel function, and overall health. MS specialists recommend that people with MS adhere to the same low-fat, high-fiber diet recommendations of the American Heart Association and the American Cancer Society for the general population. View a video about dietary approaches.
 
Q. What other dietary approaches are being tested in MS?
A. The National MS Society is supporting several clinical trials including one exploring the impacts of intermittent calorie restriction (at Johns Hopkins University in Baltimore, currently recruiting participants), and a medical food for the treatment of MS cognitive impairment (at the University of Miami, currently recruiting participants). Other trials include a study investigating the impact of dietary salt on immune function (at Yale University, New Haven, currently recruiting participants). 
 
Read more about diets and MS 

Read more about issues to think about when considering enrolling in an MS clinical trial (PDF)

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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